Trial Outcomes & Findings for GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis (NCT NCT00737672)
NCT ID: NCT00737672
Last Updated: 2014-10-21
Results Overview
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
293 participants
Primary outcome timeframe
6 months
Results posted on
2014-10-21
Participant Flow
Participant milestones
| Measure |
VIABAHN Treatment Group
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
Percutaneous Transluminal Angioplasty (PTA)in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
148
|
|
Overall Study
Exclusions Due to Protocol Deviations
|
14
|
10
|
|
Overall Study
Per Protocol Population
|
131
|
138
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
80
|
83
|
Reasons for withdrawal
| Measure |
VIABAHN Treatment Group
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
Percutaneous Transluminal Angioplasty (PTA)in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Overall Study
Graft Abandonment
|
48
|
56
|
|
Overall Study
Death
|
23
|
22
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Miscellaneous
|
7
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
Baseline characteristics by cohort
| Measure |
VIABAHN Treatment Group
n=145 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm.
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis.
|
PTA Treatment Group
n=148 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm.
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis.
|
Total
n=293 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
61.3 Years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
61.7 Years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
145 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Body Mass Index
|
29.7 Kg/m^2
STANDARD_DEVIATION 9.1 • n=5 Participants
|
29.5 Kg/m^2
STANDARD_DEVIATION 8.6 • n=7 Participants
|
29.6 Kg/m^2
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
History of Diabetes
History of Diabetes = YES
|
94 Participants
64.8 • n=5 Participants
|
98 Participants
66.2 • n=7 Participants
|
192 Participants
n=5 Participants
|
|
History of Diabetes
History of Diabetes = NO
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
History of Hypertension
History of Hypertension = YES
|
143 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
|
History of Hypertension
History of Hypertension = NO
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age of Vascular Access Graft
|
1.93 Years
STANDARD_DEVIATION 1.92 • n=5 Participants
|
2.28 Years
STANDARD_DEVIATION 2.64 • n=7 Participants
|
2.11 Years
STANDARD_DEVIATION 2.31 • n=5 Participants
|
|
Total Number of Prior Interventions at the Target Lesions
|
1.85 Number of Prior Interventions
STANDARD_DEVIATION 2.20 • n=5 Participants
|
1.81 Number of Prior Interventions
STANDARD_DEVIATION 2.34 • n=7 Participants
|
1.83 Number of Prior Interventions
STANDARD_DEVIATION 2.27 • n=5 Participants
|
|
Total Number of Prior Interventions to the Current Prosthetic Graft or Circuit
|
2.28 Number of Prior Interventions
STANDARD_DEVIATION 2.75 • n=5 Participants
|
2.26 Number of Prior Interventions
STANDARD_DEVIATION 2.90 • n=7 Participants
|
2.27 Number of Prior Interventions
STANDARD_DEVIATION 2.82 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Target Lesion Primary Patency at 6 Months
|
52.9 Percentage of Subjects
Interval 43.8 to 61.1
|
35.5 Percentage of Subjects
Interval 27.4 to 43.6
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Target Lesion Primary Patency at 12 Months
|
30.2 Percentage of Subjects
Interval 22.2 to 38.7
|
18.2 Percentage of Subjects
Interval 12.1 to 25.2
|
PRIMARY outcome
Timeframe: 24 MonthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. P-Value calculated from 24-month data cohort after study completion.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Target Lesion Primary Patency at 24 Months
|
15.7 Percentage of Subjects
Interval 9.6 to 23.2
|
9.9 Percentage of Subjects
Interval 5.5 to 15.9
|
PRIMARY outcome
Timeframe: 30 daysThe primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=145 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=148 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Six-month estimate of assisted primary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Assisted Primary Patency at 6 Months
|
56.2 Percentage of Subjects
Interval 47.1 to 64.3
|
51.1 Percentage of Subjects
Interval 42.3 to 59.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Assisted Primary Patency at 12 Months
|
43.5 Percentage of Subjects
Interval 34.5 to 52.1
|
35.3 Percentage of Subjects
Interval 27.1 to 43.6
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Assisted Primary Patency at 24 Months
|
29.2 Percentage of Subjects
Interval 21.0 to 38.0
|
29.0 Percentage of Subjects
Interval 21.3 to 37.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Six-month estimate of secondary access patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Access Secondary Patency at 6 Months
|
91.2 Percentage of Subjects
Interval 84.6 to 95.0
|
86.5 Percentage of Subjects
Interval 79.5 to 91.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=100 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=104 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Access Secondary Patency [12 Months] Units Percentage of Subjects
|
82.7 Percentage of Subjects
Interval 74.5 to 88.5
|
78.6 Percentage of Subjects
Interval 70.3 to 84.8
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. 24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=77 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=72 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Access Secondary Patency [24 Months] Units Percentage of Subjects
|
68.9 Percentage of Subjects
Interval 59.0 to 76.9
|
66.6 Percentage of Subjects
Interval 57.1 to 74.6
|
SECONDARY outcome
Timeframe: 6 monthsKaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit. P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=145 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=148 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Circuit Primary Patency
|
43.4 Percentage of Subjects
Interval 34.6 to 51.9
|
29.4 Percentage of Subjects
Interval 21.9 to 37.3
|
SECONDARY outcome
Timeframe: 12monthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=48 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=38 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Circuit Primary Patency [12 Months] Units Percentage of Subjects
|
21.4 Percentage of Subjects
Interval 14.4 to 29.3
|
15.2 Percentage of Subjects
Interval 9.6 to 21.9
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=12 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=9 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Circuit Primary Patency [24 Months] Units Percentage of Subjects
|
9.6 Percentage of Subjects
Interval 4.9 to 16.1
|
6.8 Percentage of Subjects
Interval 3.2 to 12.1
|
SECONDARY outcome
Timeframe: Following Index ProcedureThe resumption of normal dialysis for at least one session following study treatment (Index Procedure).
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Clinical Success
Clinical Success = YES
|
128 Participants
|
135 Participants
|
|
Clinical Success
Clinical Success = NO
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Index ProcedureLess than 30 percent residual stenosis following study treatment (Index Procedure).
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Anatomic Success
Anatomic Success = YES
|
131 Participants
|
116 Participants
|
|
Anatomic Success
Anatomic Success = NO
|
0 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Following Index ProcedureParticipants were considered to have Procedural Success if they achieved both anatomic success and clinical success.
Outcome measures
| Measure |
VIABAHN Treatment Group
n=131 Participants
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
|
PTA Treatment Group
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis
|
|---|---|---|
|
Procedural Success
Procedural Success = YES
|
128 Participants
|
113 Participants
|
|
Procedural Success
Procedural Success = NO
|
3 Participants
|
25 Participants
|
Adverse Events
VIABAHN Treatment Group
Serious events: 78 serious events
Other events: 4 other events
Deaths: 0 deaths
PTA Treatment Group
Serious events: 77 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VIABAHN Treatment Group
n=145 participants at risk
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
|
PTA Treatment Group
n=148 participants at risk
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.69%
1/145
|
0.68%
1/148
|
|
Blood and lymphatic system disorders
Anemia of chronic disease
|
0.69%
1/145
|
0.00%
0/148
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/145
|
0.68%
1/148
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/145
|
0.68%
1/148
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.69%
1/145
|
0.00%
0/148
|
|
Cardiac disorders
Acute coronary syndrome
|
0.69%
1/145
|
0.00%
0/148
|
|
Cardiac disorders
Anginal pain
|
2.1%
3/145
|
0.68%
1/148
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
2/145
|
1.4%
2/148
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.00%
0/145
|
0.68%
1/148
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/145
|
0.68%
1/148
|
|
Cardiac disorders
Bradycardia
|
2.8%
4/145
|
1.4%
2/148
|
|
Cardiac disorders
Cardiac arrest
|
4.1%
6/145
|
5.4%
8/148
|
|
Cardiac disorders
Cardiopulmonary arrest
|
2.1%
3/145
|
1.4%
2/148
|
|
Cardiac disorders
Chest pain
|
0.69%
1/145
|
0.00%
0/148
|
|
Cardiac disorders
Congestive heart failure
|
2.1%
3/145
|
0.68%
1/148
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
2/145
|
0.00%
0/148
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/145
|
0.68%
1/148
|
|
Cardiac disorders
Hypertensive heart disease
|
0.69%
1/145
|
0.00%
0/148
|
|
Cardiac disorders
Junctional bradycardia
|
0.69%
1/145
|
0.00%
0/148
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
2/145
|
0.00%
0/148
|
|
Cardiac disorders
Myocardial infarction
|
2.8%
4/145
|
0.00%
0/148
|
|
Cardiac disorders
Non STEMI
|
2.1%
3/145
|
0.68%
1/148
|
|
Cardiac disorders
Tachycardia NOS
|
0.69%
1/145
|
0.00%
0/148
|
|
Congenital, familial and genetic disorders
Polycystic hepatorenal disease
|
0.69%
1/145
|
0.00%
0/148
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/145
|
0.68%
1/148
|
|
Eye disorders
Blurry vision
|
0.69%
1/145
|
0.00%
0/148
|
|
Eye disorders
Cataract
|
0.69%
1/145
|
0.00%
0/148
|
|
Eye disorders
Retinal detachment
|
0.69%
1/145
|
0.00%
0/148
|
|
Eye disorders
Retinal vascular occlusion
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Abdominal pain aggravated
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Acute duodenal ulcer with hemorrhage
|
0.00%
0/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.00%
0/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Bleeding gastric ulcer
|
0.00%
0/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Blood in stool
|
1.4%
2/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Colitis
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.69%
1/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Diverticulum intestinal hemorrhagic
|
0.00%
0/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
GI bleed
|
2.1%
3/145
|
1.4%
2/148
|
|
Gastrointestinal disorders
Gastritis
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Gastroparesis
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Hematochezia
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Internal hemorrhoids
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Lower gastrointestinal bleeding
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Mesenteric ischemia
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Pancreatitis acute on chronic
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Pancreatitis due to gallstones
|
0.00%
0/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Peptic ulcer disease
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Right-sided colitis
|
0.69%
1/145
|
0.00%
0/148
|
|
Gastrointestinal disorders
Small bowel obstruction
|
1.4%
2/145
|
0.68%
1/148
|
|
Gastrointestinal disorders
Upper gastrointestinal bleeding
|
1.4%
2/145
|
1.4%
2/148
|
|
Gastrointestinal disorders
Upper gastrointestinal symptoms
|
1.4%
2/145
|
0.00%
0/148
|
|
General disorders
Adverse drug reaction
|
0.00%
0/145
|
0.68%
1/148
|
|
General disorders
Catheter site bleeding
|
0.69%
1/145
|
0.00%
0/148
|
|
General disorders
Chest pain
|
5.5%
8/145
|
4.1%
6/148
|
|
General disorders
Debility marked
|
0.00%
0/145
|
0.68%
1/148
|
|
General disorders
Ill-defined disorder
|
0.00%
0/145
|
0.68%
1/148
|
|
General disorders
Incarcerated hernia
|
0.00%
0/145
|
0.68%
1/148
|
|
General disorders
Intraocular lens dislocation
|
0.00%
0/145
|
0.68%
1/148
|
|
General disorders
Pain at rest
|
0.00%
0/145
|
0.68%
1/148
|
|
General disorders
Peritoneal catheter dysfunction
|
0.00%
0/145
|
0.68%
1/148
|
|
General disorders
Sudden cardiac death
|
0.69%
1/145
|
0.00%
0/148
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.69%
1/145
|
0.00%
0/148
|
|
Hepatobiliary disorders
Biliary stasis
|
0.69%
1/145
|
0.00%
0/148
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
2/145
|
0.68%
1/148
|
|
Immune system disorders
Allergic reaction to antibiotics
|
0.69%
1/145
|
1.4%
2/148
|
|
Infections and infestations
Abscess dental
|
0.00%
0/145
|
0.68%
1/148
|
|
Infections and infestations
Abscess leg
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Abscess of finger
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Acute tracheobronchitis
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Arteriovenous graft site infection
|
3.4%
5/145
|
6.1%
9/148
|
|
Infections and infestations
Bacteremia
|
3.4%
5/145
|
0.00%
0/148
|
|
Infections and infestations
Bacterial endocarditis
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Biliary sepsis
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Bronchitis
|
2.1%
3/145
|
0.00%
0/148
|
|
Infections and infestations
C.difficile colitis
|
1.4%
2/145
|
0.00%
0/148
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/145
|
0.68%
1/148
|
|
Infections and infestations
Cellulitis
|
1.4%
2/145
|
0.00%
0/148
|
|
Infections and infestations
Cellulitis of arm
|
0.00%
0/145
|
0.68%
1/148
|
|
Infections and infestations
Cellulitis of foot
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Cellulitis of leg
|
1.4%
2/145
|
0.00%
0/148
|
|
Infections and infestations
Cellulitis of legs
|
0.00%
0/145
|
0.68%
1/148
|
|
Infections and infestations
Community acquired pneumonia
|
1.4%
2/145
|
0.68%
1/148
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/145
|
0.68%
1/148
|
|
Infections and infestations
Diverticulitis
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Foot infection
|
1.4%
2/145
|
0.00%
0/148
|
|
Infections and infestations
Gangrene
|
3.4%
5/145
|
3.4%
5/148
|
|
Infections and infestations
Hospital acquired infection
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Infection of amputation stump
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Leg infection
|
0.69%
1/145
|
0.68%
1/148
|
|
Infections and infestations
Osteomyelitis
|
2.1%
3/145
|
0.68%
1/148
|
|
Infections and infestations
Pneumonia
|
1.4%
2/145
|
5.4%
8/148
|
|
Infections and infestations
Pneumonia aspergillus
|
0.00%
0/145
|
0.68%
1/148
|
|
Infections and infestations
Recurrent urinary tract infection
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Sepsis
|
3.4%
5/145
|
3.4%
5/148
|
|
Infections and infestations
Sepsis MRSA
|
0.69%
1/145
|
1.4%
2/148
|
|
Infections and infestations
Septic shock
|
2.1%
3/145
|
0.00%
0/148
|
|
Infections and infestations
Shingles
|
0.00%
0/145
|
0.68%
1/148
|
|
Infections and infestations
Staphylococcal bacteremia
|
1.4%
2/145
|
0.68%
1/148
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/145
|
1.4%
2/148
|
|
Infections and infestations
Streptococcal cellulitis
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Urinary tract infection
|
1.4%
2/145
|
2.7%
4/148
|
|
Infections and infestations
Urosepsis
|
0.69%
1/145
|
0.00%
0/148
|
|
Infections and infestations
Viral syndrome
|
0.00%
0/145
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Acute subdural hematoma
|
0.69%
1/145
|
0.00%
0/148
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.69%
1/145
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Arteriovenous graft aneurysm
|
0.69%
1/145
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site bleeding
|
2.8%
4/145
|
2.0%
3/148
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site hematoma
|
0.00%
0/145
|
1.4%
2/148
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site hemorrhage
|
0.69%
1/145
|
0.00%
0/148
|
|
Injury, poisoning and procedural complications
Bleeding postoperative
|
0.69%
1/145
|
0.00%
0/148
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture C2
|
0.69%
1/145
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Fall
|
0.69%
1/145
|
0.00%
0/148
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.00%
0/145
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.69%
1/145
|
0.00%
0/148
|
|
Injury, poisoning and procedural complications
Fracture of upper end or unspecified part of tibia and fibula, closed
|
0.69%
1/145
|
0.00%
0/148
|
|
Injury, poisoning and procedural complications
Hemodialysis-induced symptom
|
0.00%
0/145
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.69%
1/145
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Hypotension during dialysis
|
0.00%
0/145
|
1.4%
2/148
|
|
Injury, poisoning and procedural complications
Lower limb wound
|
0.69%
1/145
|
0.00%
0/148
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/145
|
1.4%
2/148
|
|
Injury, poisoning and procedural complications
Postoperative bleeding
|
0.00%
0/145
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/145
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.69%
1/145
|
0.00%
0/148
|
|
Investigations
Electrocardiogram abnormal non-specific
|
0.69%
1/145
|
0.00%
0/148
|
|
Investigations
Troponin increased
|
0.69%
1/145
|
0.00%
0/148
|
|
Metabolism and nutrition disorders
Diabetes mellitus poor control
|
0.69%
1/145
|
0.00%
0/148
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
3.4%
5/145
|
1.4%
2/148
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
2/145
|
0.00%
0/148
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.1%
6/145
|
4.7%
7/148
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.69%
1/145
|
0.68%
1/148
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/145
|
2.0%
3/148
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.69%
1/145
|
0.68%
1/148
|
|
Metabolism and nutrition disorders
Volume overload
|
7.6%
11/145
|
3.4%
5/148
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis femoral head
|
0.69%
1/145
|
0.00%
0/148
|
|
Musculoskeletal and connective tissue disorders
Hand pain
|
0.00%
0/145
|
0.68%
1/148
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.69%
1/145
|
0.00%
0/148
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.69%
1/145
|
0.00%
0/148
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis aggravated
|
0.69%
1/145
|
0.00%
0/148
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis of cervical spine
|
0.00%
0/145
|
0.68%
1/148
|
|
Musculoskeletal and connective tissue disorders
Pain in arm
|
0.69%
1/145
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.69%
1/145
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.69%
1/145
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic adenocarcinoma
|
0.00%
0/145
|
0.68%
1/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/145
|
0.68%
1/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/145
|
0.68%
1/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/145
|
0.68%
1/148
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
2/145
|
2.7%
4/148
|
|
Nervous system disorders
Dizziness
|
0.69%
1/145
|
0.00%
0/148
|
|
Nervous system disorders
Encephalopathy acute
|
0.00%
0/145
|
1.4%
2/148
|
|
Nervous system disorders
Slurred speech
|
0.69%
1/145
|
0.00%
0/148
|
|
Nervous system disorders
Stroke
|
0.69%
1/145
|
0.00%
0/148
|
|
Nervous system disorders
Syncope
|
1.4%
2/145
|
0.68%
1/148
|
|
Nervous system disorders
Tonic-clonic seizures
|
0.00%
0/145
|
0.68%
1/148
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/145
|
0.68%
1/148
|
|
Nervous system disorders
Transient ischemic attack
|
1.4%
2/145
|
0.68%
1/148
|
|
Nervous system disorders
Tremor
|
0.00%
0/145
|
0.68%
1/148
|
|
Psychiatric disorders
Mental status changes
|
2.1%
3/145
|
1.4%
2/148
|
|
Renal and urinary disorders
End stage renal disease (ESRD)
|
1.4%
2/145
|
2.7%
4/148
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/145
|
0.68%
1/148
|
|
Renal and urinary disorders
Kidney failure
|
0.69%
1/145
|
0.00%
0/148
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/145
|
1.4%
2/148
|
|
Renal and urinary disorders
Uremia
|
0.00%
0/145
|
1.4%
2/148
|
|
Respiratory, thoracic and mediastinal disorders
Acute on chronic respiratory failure
|
0.69%
1/145
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.69%
1/145
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.69%
1/145
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.69%
1/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Flash pulmonary edema
|
0.00%
0/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
0.00%
0/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary edema
|
0.00%
0/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnea
|
0.00%
0/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.69%
1/145
|
1.4%
2/148
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infiltration
|
0.69%
1/145
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
2/145
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.69%
1/145
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord dysfunction
|
0.69%
1/145
|
0.00%
0/148
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/145
|
0.68%
1/148
|
|
Skin and subcutaneous tissue disorders
Facial swelling
|
0.69%
1/145
|
0.00%
0/148
|
|
Skin and subcutaneous tissue disorders
Foot ulcer
|
0.00%
0/145
|
0.68%
1/148
|
|
Skin and subcutaneous tissue disorders
Heel ulcer
|
0.69%
1/145
|
0.00%
0/148
|
|
Skin and subcutaneous tissue disorders
Leg ulcer
|
0.69%
1/145
|
0.00%
0/148
|
|
Skin and subcutaneous tissue disorders
Venous stasis ulcer
|
0.00%
0/145
|
0.68%
1/148
|
|
Surgical and medical procedures
Anticoagulant therapy
|
0.69%
1/145
|
0.00%
0/148
|
|
Surgical and medical procedures
Blood pressure management
|
0.69%
1/145
|
0.00%
0/148
|
|
Surgical and medical procedures
Kidney transplant
|
0.69%
1/145
|
0.00%
0/148
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/145
|
0.68%
1/148
|
|
Vascular disorders
Accelerated Hypertension
|
0.69%
1/145
|
0.00%
0/148
|
|
Vascular disorders
Arterial embolism NOS
|
0.00%
0/145
|
0.68%
1/148
|
|
Vascular disorders
Atherosclerosis of arteries of the extremities
|
0.69%
1/145
|
0.00%
0/148
|
|
Vascular disorders
Critical limb ischemia
|
0.69%
1/145
|
0.00%
0/148
|
|
Vascular disorders
Deep venous thrombosis arm
|
0.00%
0/145
|
0.68%
1/148
|
|
Vascular disorders
Hypertension
|
0.69%
1/145
|
0.68%
1/148
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/145
|
0.68%
1/148
|
|
Vascular disorders
Hypertensive urgency
|
0.69%
1/145
|
1.4%
2/148
|
|
Vascular disorders
Malignant hypertension
|
0.69%
1/145
|
0.68%
1/148
|
|
Vascular disorders
Peripheral arterial disease
|
0.69%
1/145
|
1.4%
2/148
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/145
|
1.4%
2/148
|
|
Vascular disorders
Uncontrolled hypertension
|
0.69%
1/145
|
0.00%
0/148
|
|
Vascular disorders
Venous (peripheral) insufficiency, unspecified
|
0.69%
1/145
|
0.00%
0/148
|
Other adverse events
| Measure |
VIABAHN Treatment Group
n=145 participants at risk
Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
|
PTA Treatment Group
n=148 participants at risk
Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
|
|---|---|---|
|
General disorders
Chest pain
|
2.8%
4/145
|
5.4%
8/148
|
Additional Information
Clinical Project Manager
W.L. Gore and Associates, Inc.
Phone: 928-864-3771
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place